Device Classification Name |
activated whole blood clotting time
|
510(k) Number |
K013078 |
Device Name |
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 |
Applicant |
HELENA LABORATORIES |
1530 LINDBERGH DR. |
P.O. BOX 752 |
BEAUMONT,
TX
77704
|
|
Applicant Contact |
PATRICIA FRANKS |
Correspondent |
HELENA LABORATORIES |
1530 LINDBERGH DR. |
P.O. BOX 752 |
BEAUMONT,
TX
77704
|
|
Correspondent Contact |
PATRICIA FRANKS |
Regulation Number | 864.7140
|
Classification Product Code |
|
Date Received | 09/14/2001 |
Decision Date | 01/10/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|